Quality System

Our sound quality system with extensive certifications demonstrates our commitment in quality, integrity and competency

Our top-rated Quality System is designed to meet global regulatory expectation and follows the laws, regulations and rules for CMC activities, including:

  • Requirements of US 21 CFR Part 210, 211, and 600 governing Good Manufacturing Practices (“cGMP”)
  • Requirements of US 21 CFR Part 11 governing computerized systems used in the processing of drugs
  • Rules Governing Medicinal Product in the EU (EudraLex)
  • Requirements of China NMPA Good Manufacturing Practices
  • Applicable ICH Guidelines

At Chime Biologics, we adopt a continuous improvement approach for our quality system. The system is constantly and proactively being tested for enhanced performance via internal reviews and external (client and regulatory) audits. Our quality personnel are extensively trained to promptly identify operational risks, effectively collect associated data and efficiently implement corrective measures.  This institutionalized quality effort demonstrates our commitment to operational excellence, product quality and the ultimate patient safety.